What You Need To Know About Article 10a Before January 10, 2025 (2)

Webinar. Hello, and welcome everybody. I'm so glad that you're able to make it today for what you need to know about Article 10 a before January 10, th 2025. Today's speakers are Dr. Bastille, Akra, Eric Fulbrecht, Lawrence Yeh, and I'm your host, Sean Smith. A few housekeeping announcements before we get started. the slides and the recording will be available tomorrow. You should all get an email with that. Those wishing to receive a certificate of attendance today should provide their name as they would like it to appear on the certificate along with their email address in the chat function. So use the chat function vigorously throughout this webinar. We want your questions. We look forward to your questions.

Make sure you subscribe to medtech leading voice. save the date. Tuesday, January 21st join Richard Hallborough. Nebosha. Oh, Sarah, I'm sorry. Thank you. And Matthias Fink for orphan devices in the EU. This is going to be awesome. Another acro team event follow acra team on Linkedin. I'm going to put all these links in the thing. And then, lastly, so I'm not sure if the survey is going to pop up by itself at the end of the thing, or be sent to you. But in the event that you do not get it. I'm putting the link to the survey directly in the thing. Now questions when you have questions, put them in the Q&A thing, and when we get to the Q&A section I will queue up the Q. And a. For everybody.

If you have any questions for me, put them in the chat, so going to turn it over to Lawrence to get us started.

Thank you very much. Sean, just gonna put up our slides here and we can get started. Is this coming through? Okay?

Yes.

Wonderful excellent. So today's webinar is called what you need to know about Article 10 a. Before January 10, th 2025, and it's intended for economic operators under the Ndr. And Ivdr. Including manufacturers, authorized representatives, importers, and distributors. What you'll see in here today includes information from the regulation EU 2024, 1860, which was published in the official journal on the 9th of July 2024, and some key points from revision, one of the Q. And a document originally published by the EU Commission in October, and revised just this month in December.

So this webinar will feature the opinions and interpretations of myself and the 2 guest speakers. So please take note of this disclaimer on today's agenda. We will walk through your new and upcoming obligations described in Article 10 a. Including how to interpret some of the gray Areas. I will present some ideas about what you need to have done yesterday. Given the fast approaching date of January 10, th and then we will have a panel discussion with our 2 guest speakers, Dr. Basil Akra and Eric Bulbrecht. After that we will have some time for some questions which were submitted before the event, and we can take some questions from the live audience

Sean has already mentioned. So let's start with a diagram to help visualize things at the core of Article 10 A. Is this communication chain? You can see each stakeholder must inform the next stakeholder of anticipated that is reasonably foreseeable product interruptions or discontinuations. And specifically. we're talking about those that could result in serious harm to patients or public health. So you see, the manufacturer informs the competent authority who informs other confident authorities and the European Commission. and depending on how the manufacturer places the devices on the market. The manufacturer directly informs the health institutions and healthcare professionals to whom they supply devices, or the manufacturer informs the importers and distributors who then pass on the message.

We will come back to this diagram shortly, but in a nutshell this is the key aspect of Article 10, a. This cascading communication. and in essence it is a mechanism allowing the Member States to identify product shortages. Right? That was the intention of the lawmakers, knowing that they have regulatory bottlenecks to somehow become aware of device shortages early enough to be able to react. They don't need to know all product shortages, only some. So let's talk about the scope and other details. Article 10. A. Applies to all devices under the Mdr. And Ivdr. Except custom-made devices

that have been placed on the Union market, and this includes all legacy devices. It's very important to understand what is in scope here. But then, for all such devices, Article 10, A requires certain actions in these following conditions. Number one. A temporary inability or unwillingness on the manufacturer's part to place a device on the market. You can use 60 plus days as a guideline. But this is not a strict rule. and that this supply interruption would result in a serious harm to patients of public health or number 2 that there is a permanent cessation cessation, so the manufacturer will permanently stop placing a device on the market. And again, that this discontinuation could result in serious harm.

So right away you can see there are some nuances to these conditions that we must explore clearly. So let's dive a little bit deeper. Let's talk about the roles and responsibilities. So who is performing this initial communication under Article 10 A. It's the manufacturer of devices placed on the unit market, including legacy devices that are responsible for the initial communication they need to have a system in place to identify when either of those 2 conditions we just talked about have been triggered. This will involve some communication within the organization, and with external. So stakeholders like suppliers who are not pictured in this diagram.

Now, who is receiving the communication. First, st there's the competent authority in the Member States where the manufacturer is located. If the manufacturer is outside the EU. Of course, then it is the competent authority where the authorized representative is located. Other recipients of the communication include all relevant importers and distributors. We have a dotted line here in case they're not used. And then there are the health institutions which are defined as the organizations with primary purpose to care or provide treatment to patients or promote public health. This comes from the Mdr itself.

and healthcare professionals that are impacted by the supply or supply interruption or discontinuation. Any importers, if any are going to inform all of their impacted distributors, and similarly those distributors would then inform all the downstream health institutions and healthcare professionals. Now the manufacturer is the source of this information being passed on. and the Q. And a document published by the EU Commission clarifies that these stakeholders should not be making any changes to this information. If there are any amendments or follow-ups, they should really originate from the manufacturer.

Now, what is in this notification or information that's being communicated. Well, just recently the Manufacturer Information Form was published to standardize this activity, Mdcg. 2024 to 16. If you are not aware that it was published. I suggest you run to your favorite Internet search engine and type it in Mdcg. 2024 to 16. On this form, aside from the usual administrative information, such as manufacturer and device identification. You need to categorize the interruption or discontinuation and identify if it was a regulatory supply chain or manufacturing issue or something else altogether.

You need to identify the reasons why this might present a risk of serious harm. such as the device being a life sustaining or life-saving device or accessory. or a device intended for vulnerable population, such as pediatric or geriatric patients, and whether or not the lack of the device on the market would prevent patients from accessing treatment. while the categories on the form can provide some hints or clues about how to interpret the risk associated with this supply interruption or discontinuation. There is also an other category, so the options on the form are not a complete or exhaustive list.

There are also many sections on a document which are marked as voluntary. So please do read the form carefully, and familiarize yourself with the contents. and finally, there is also an annex document. the annex to Ndcg. 2024 to 16, and this actually provides a table for identifying all the devices in scope of the supply, interruption or discontinuation. Now, what about the timing of the communication? If the issue is reasonably foreseeable. the notification must occur 6 months at least 6 months prior to the anticipated supply interruption or discontinuation.

Now there are exceptional circumstances which are defined as unforeseen situations, where the manufacturer is unable to anticipate this spine disruption or discontinuation. and some of the examples listed include natural disasters, a sudden inability to obtain raw materials or components. economic or financial circumstances. These are situations where the manufacturer must simply inform the stakeholders without undue delay. And similarly, the passing on of information from, let's say, important distributors for along the supply chain that must also occur without delay. And remember, it's not expected that this information is amended or edited in any way, so they don't have an excuse to delay the communication.

The key challenge here will be how fast they can identify the downstream supply chain. My experience from auditing various economic operators. This process will test the ability of some importers and distributors to quickly identify all the relevant customers of a particular device. Now, the terms of the start of applicability, the regulation itself is already, in effect, the overall regulation which made amendments, the reporting requirement for 10, a starts as of January 10, th 2025. So this means that if on January 9th you realize that there may be a supply interruption, discontinuation. Technically, this regulation does not apply.

If you've already ceased supplying for other reasons unrelated, then those stakeholders do not necessarily need to be informed. As a result of this. this point is clarified in the Q&A. Under number 4. What about the serious harm aspect? So the Q&A clarifies that we're talking about cases where, let's say, a particular diagnosis method or patient therapy is unavailable. and a healthcare professional cannot deliver a specific medical treatment or situations where a serious injury occurs, or there's a significant probability of it occurring imminent risk of death, serious deterioration of patient health, as defined in Ndcg. 2020 to 3.

Those are the things you want to consider. You can also get some clues from the manufacturer. Information form earlier. I mentioned that the categories listed can suggest some situations such as a device used in a serious, acute, or chronic pathology. Then there's the question of what is reasonably foreseeable. So manufacturers need to understand the triggers that qualify as anticipating the interruption or discontinuation. It's based on their own internal analysis and confirmation that there will be an interruption, discontinuation, for whatever reason it could be supply chain activities, it could be their own capabilities or limitations.

Maybe they make decisions due to business, economic or financial reasons. I encourage everyone to read through the Q. And a document very carefully. It talks about how the manufacturer does not need to consider whether other devices from other manufacturers can be used. or necessarily the stock levels. or they don't need to conduct a comprehensive market analysis. In other words, they need to focus on their own portion of the supply chain the information that is available to them between them and their direct importers, distributors. and customers. This point is clarified in Q&A. Number 7, and what's more, I just want to emphasize the importance of knowing what devices are in scope. Right? It's all devices on the market, including legacy devices excluding custom made.

And you want to know all the possible reasons for supply interruption or discontinuation, such as not having a valid certificate or not deciding to not pursue certification anymore. Device performance issues difficulties in obtaining components necessary for manufacturing or other disruptions in your supply chain. All of those need to be considered. So what should you focus on right now? It is mid December. Everyone's getting ready for holidays. What do you need to do for the manufacturers? Make sure you understand the triggers to look out for these triggers that indicate when you should proactively perform an assessment. Consider regulatory issues like no longer fulfilling the transition requirements for legacy devices under under Article 120 of the Mdr. 110 of the Ivdr.

Consider business decisions to no longer pursue certification. Right? It's not just about your supply chain issues with components, raw materials. and understand situations that are not triggers like, can you replace device with a successor device with a similar intended purpose? Do you have enough stockpiled devices to fulfill any demand, so that you don't really have an interruption longer than plus minus 60 days. The Q. And a. Includes a scenario where the manufacturer can receive confirmation from health institutions, that this would not necessarily provide any harm, so figure out ways of being able to establish this communication

number 2. Once you understand this range of possibilities, think about how you're going to implement it right? Find a way to proactively identify things with a 6 month horizon. Look into your monitoring activities. Do you have good relationships with your suppliers? Right? If there was an issue? Would you know. especially for sole source parts. What about communications with product marketing teams? Top management? How will you find out that there is a pending decision to discontinue a product who's going to perform the assessment internally. And how are they going to get the information about whether or not there's a suitable successor device or alternative solution?

Make sure you can communicate with all the other stakeholders. Right? Can you communicate with the health institutions? Can you communicate with your imports and distributors? You can consult with physicians, societies, associations, etc, to gather information. But just remember that you're not looking at it on individual patient cases, but for the entire population for which the device is intended. Again, you can look to Q&A. Number 9 for more guidance on this topic. After this it's time to revisit your procedures and agreements. Look to your Qms. Do your agreements with your economic operators allow you to have this communication? Are the triggers going to be in place?

Do you know who to contact when there's something wrong? We've got the manufacturer information form released. But the other thing that they promised was the decision tree diagram. So look out for this publication which should help with the decision-making process about assessing the risk, and whether or not to start the domino effect and finally look out for additional information from the competent authorities. There they may release other information that provides specific guidance applicable to their regions on this topic.

Now, before we turn over to our panel discussion. I think we're just going to do a very quick poll from the audience. So maybe I'll throw it over to Sean up there. He's got it on the screen. So you guys should be able to just plug this in. we'd appreciate any input and in the meantime, I guess we will jump over to our panel discussion unless Sean wants to say something.

Just a quick remark. So there may have been something wrong with the survey. So I'm gonna include the survey at the end in the chat, if everybody will please complete the survey. And we have lots of questions coming in through the Q. And a. As well as through the chat. We may not get to all of them, but we will try to follow up with you afterwards, if we do not. Those are my remarks.

Wonderful. Thank you. Sean. Okay, so let's dive into the panel discussion, then. So 1st question is for both of you. January 10, is just around the corner. We've just seen the release of the manufacturer. Information form. Do you have any rumors or inside knowledge about when manufacturers can expect the decision tree diagram to be published.

The decision tree. I have absolutely no idea. Do you, vessel.

No, actually, I mean what we can expect. that Commission and the Member State are working on on preparing these documents, and we will get surprises over Christmas, potentially, because end of the year they are working hard to get all what is needed. But I would not be surprised that we'll get the decision tree after January 10, like we did it in the past for other obligations. I do not recommend people to wait for something which we don't know. When is the date, Lawrence? I think you did a good presentation where you explained to us what we need to do, and there is one bullet point which you added, which is very valuable

you mentioned. We need to prepare. We need to build our process. We need to train our resources. We need to work on our agreement. The decision tree might help us, perhaps doing the micro adoption of what we have built. But 1st of all we need to build the foundation for the system which is expected to be ready by 10th of January.

Yeah. And there's nothing that prevents you also from making your own decision tree. Right? I mean this, this is what you could also do as part of preparing your procedures so normally. If you prepare your procedures, I mean I would always science the shit out of it, as they say in the Martian, and that means that you try to understand. How does it work logically? And if you have an idea about that, you can put it in a flow chart. and then compare it to the flow chart that that in the end is published. And the good part is that I mean, if it's the the commission. Q. And A is fairly detailed, although not on all points

which would basically allow you to make a a pretty good flow chart already. I mean, I made mine. And I think it's it's already pretty detailed. But yeah, we can always compare.

Yeah. And I think you know, you're mentioning something very important, Eric. Reality is. It? Is the manufacturer obligation to meet the law. All of these guidance are actually recipes on how you can actually address the requirement. But the recipes are not stipulated word by word in the law. The lawmaker told us. Actually, this is what we need to have. We need to have a system in place to report about potential interruption of devices not being available on the market that are essential for the healthcare system, and the guidance will help us understand what is written there. And even if we get a decision tree, it will potentially not address all cases. So it makes sense that you look to it by yourself. The system where you can live with it, and you can show that it's compliant to what the law is saying to us.

And actually you might even influence the decision tree in the end by having a better one yourself, because what you always see invariably with this kind of legislation that at the beginning notified bodies and even Member States, if they take a look in your kitchen, they are learning as much as you are. And they, they will typically start with looking at things like that and learning themselves. So actually, it's it's very beneficial to do your homework on these things and show that you also have thought about how to make this work. Because I think there's one thing really important about this this commission. Q. And a. And I think Besil also also expressed that already it is very much built on the thinking that it is the the manufacturer's prerogative to take this decision, based on the information that he has.

So that also underlines that. Yeah, you can sit and wait until the Commission may deliver a flow chart in the end. But then, by that time, yeah, you could already have implemented procedures yourself. That would also be okay, actually, or would fit in this so waiting, especially in this case, I don't think it's a it's a very good idea.

I think Lawrence gave them a recipe already to be honest, because he gave a good presentation with bullet point and explanation, and he referenced the various questions and answers that were provided by.

Absolutely. Yeah.

Which which can help them actually looking to those actually key points and prepare themselves, because at the end also, the notified body will look to your process to see if your process is suitable to address the requirement. They will not look to whether you are actually applying a decision tree from the Commission. They want to know how you're going to do it, and you need to show them your methodology, the guidance. Help us always understand how is the current understanding of a requirement, and this will allow us to improve. But I think you need to work it for yourself, because, if not, you will create for you a system which you can't live with it as well.

Yes, thank you.

And guidance is guidance. It always gives you room to maneuver.

Yep, I agree.

And in line with this whole question about how you decide when to actually make a report. The Q. And a. Talks about what is an exceptional circumstance. Define it as here I quote, when a manufacturer is unable to anticipate or confirm a supply, interruption and discontinuation at least 6 months in advance. for instance, natural disaster. an interruption due to a sudden inability to obtain raw materials or components, or a discontinuation due to unexpected circumstances. including an economic or financial nature. So question for you, Eric, I imagine a situation where a manufacturer doesn't think they need to discontinue a product right? Maybe they think their financial situation will change. But then, suddenly, maybe, the board makes a decision to shut down the product line.

Is there some legal gray area here? How does one argue that the manufacturer should have anticipated that discontinuation.

Yeah. So the should have is, of course, that's very much a moral way to look at it. Basically, this is about information that in the end is supposed to help competent authorities and health institutions take mitigating measures. Now the good part is that the that the Q. And a. Say, well, and also the legal text. By the way, say, okay, there can be. There can be circumstances in which, as a manufacturer, you do not have a 6 month horizon on what's going to happen like, for example? your regulatory department makes a mistake with respect to your legacy device certificate, for example, because they merged the manufacturer into another legal entity, and then the manufacturer is gone, and hey! Your certificate is gone, and suddenly you can't place these products on the market anymore.

It happens and it's avoidable. But it happens and that means that, yeah, this is something you could reasonably foresee. No, I mean, that's that's that's that's that's an internal circumstance that you do not have a 6 month horizon right? And the same, for example, with with external suppliers. Typically, if you have a if you have a critical supplier of a particular raw material or a component, and they go bankrupt, or what also happens? If it's a critical supplier it might be that their management decides. Yeah, if we have a contract for supply with you.

Yeah, you're a medical device company. We also have to submit to unannounced audits. We don't like that very much. We terminate the the supply agreement, and you cannot switch to another supplier in time. Yeah, this is also something that you usually may not have like a 6 month horizon for. So that's why the the yeah, the guidance, and also the legal provision, always gives you room to work with external circumstances by saying. we would like you to report at the 6 months horizon. But if you count, then report as soon as you know, that is basically the rule. And of course they've written it down in a bit of stern way to make it

to yeah, incentivize companies to try and meet the 6 months. Right? So basically, you need a justification if you don't. But I mean, if there is a justification, then yeah, I mean. a few months is better than no months. For example.

Yeah, I think, Eric, if what what you just mentioned makes fully sense and what we should remember the reason for this, what they are trying to achieve with that. So there is no push here than having every single case reported at day 6 months. The intention is actually to protect the healthcare system. The intention is to protect the healthcare system from systematic interruption of availability of products. and this is what they are looking for. There will be always cases which are like borderline, where you wouldn't be able to report on time. But this is for you also as a manufacturer, a critical case, because, in effect, like Eric was describing isn't actually for the manufacturer a happy day, because when they got such a contractual agreement cancellation.

it's for them, anyhow, disaster because they suddenly are not able to manufacture or place device on the market. So even that manufacturer is in bigger trouble than actually talking about the interruption, because he's not himself intending to do that. And it happens. And I think the lawmaker wanted to make us actually to protect the patients, protect the healthcare system in Europe. And they said, We want to have that information. and it doesn't need to be seen as a negative impact on the manufacturer, because in some circumstances authorities will support manufacturers, having, perhaps, in a case where a certificate is not available anymore.

interrogation, special release, support them, actually being able to get device on the market. I think we should look to it in a way where it could be positive also for some manufacturer to have such a system. Yes, it is an additional burden, but it is intended to protect the healthcare system. and you will not be punished if you didn't report every single case at 6 months advance notice, you will have cases where you have a surprise, and this is where they are telling us. Build your system for the typical cases and have a system for actually unknown cases where you can be surprised. But tell us about this because we don't want to punish you for that we want to just get the awareness and perhaps work with you and others to make sure that the healthcare system continuity is assured.

Wonderful. Thank you. Next next question is for Basil, in your experience as a consultant and a notified body auditor, do you think manufacturers generally have the ability to forecast 6 months in advance, or what are some common areas of weakness that manufacturers should consider.

I think I mean, we discussed this already. Multiple time. Do they have the ability? It's not. Every manufacturer have sufficient resources to address additional obligation. I think we were talking about resources limitations since many years, and it's getting more and more more and more obligations. Are they able to build a system for this. Yes, they can build. Every manufacturer can build the system. But we should not forget that manufacturers are not always 20,000 employee manufacturers, and we should also remember the small ones that they might be overloaded with such a task. Now, can they do it? I mean

having a system like this. Theoretically, it's doable. But reality we are talking about actually setting expectation or predicting what's going to happen in the future. And who's from us can predict what's going to happen tomorrow? We can't. Even so, I think that the typical case where you know, is like business decisions. But does everyone in the business knows about actually future decisions on closure, perhaps of a site. Some manufacturers, some management, might not want to know or to communicate internally about decisions like that very early, because this can put them in a competitive. a limitation where they want to avoid it. That's why they keep it to the last moment. Now, by getting this obligation. They are actually getting an expectation that management cannot actually take business decision anymore freely, because they are limited to communicate that and predict that, and tell the people about what they want to do, what they don't want to do.

And we are not talking always about high risk devices. We are talking also about devices which might be necessary to support other devices. And there are a lot of cases, and I think Eric and yourself elaborated a bit about it. Setting a system for a standard case, it would be potentially possible. But setting a system which is addressing business decisions, addressing supply chain, addressing the various critical impacts that might lead to such a limitation or interruption in the market. It will be tough even for the biggest manufacturer, because it's not just about resources. It's about how much information do I have to be able to do such a prediction? And if I predict and communicate that I might have in 6 months an interruption.

and this gets the awareness of my competition. I might kill my market as well, because my competition will got that awareness, and they will start building the stock because we saw it already in many examples, and I think Eric as well, and others saw it by authorities contacting manufacturers, saying, we have in our region some limitation with regard to devices, and those manufacturers are not able to deliver product. Are you able to provide us with these stock products because we need them. And this is leading to a big impact on your ability to have your market share again. If you communicate something where you are not sure about it. It might have an impact on your market share and your business continuity as a manufacturer, because you want it to be risk dating. But then you created for yourself a business risk.

That's very interesting point about how it it causes this conflict where they have to decide. Well, which which obligation are we gonna fulfill first, st are we gonna perform the early notification, or are we gonna have to change our decision?

Yeah, you never know, because even what you predict, 6 months in advance might not be reality. But it could be also more than that. And all of these predictions are always like big assumptions. Therefore it requires us, if we build a system, that we have a very good due diligence early in that step to look into whether it will happen or not. You know you have cases where you know it doesn't work, because suddenly there is like an ashquake, something damaged, the whole manufacturing. You cannot build it in 6 months period again, and if there is one single supplier, then you are in trouble. Same case like Eric was mentioning. If I had a supplier who said, like, I don't want to sign an agreement with you, and you are dependent on that single supplier, finding an alternative will not be easy. So all of these things might take a lot of time, and especially what you mentioned in your presentation. The agreement piece, you know, even if you find someone. Sometimes agreement piece takes longer than a year to get to an agreement and an alignment which is stipulating the obligation and the expectation from both sides.

Yes, and the audits I've done. That is a common, weak area, for sure, those agreements with economic operators. And you're absolutely right. It can take a lot of time to get the agreement set up, especially if the manufacturer is maybe a smaller player, let's say, and it's a very large importer, or large, supplier, or whatever absolutely, that is a huge.

Think Eric can tell you a lot about these kind of situation where you know you need to look also on what I'm communicating to the authority, because I'm sharing information which can have a big impact on me as an organization and legal review should be also done to protect the business from unnecessary harm as well on top to all what we are doing now trying to protect the patient. But there is an impact on my availability as a manufacturer later on, because my market share will be damaged, due to very early communication, or something which might not be reality.

Yeah, yeah, this is a really good one. Because, because there is so much risk, basically for yeah, damaging your competitive position in the market, for example. one of the things is, what kind of information are you going to supply, for example? Because if you, if you look at the guidance. There are 2 groups that you should provide information to competent authority and economic operators. There is a form that you need to provide to the competent authority. But there is no form for information that you should provide to economic operators. And it is also very unclear in the Q&A basically, there's 0 detail on this. What information? Specifically, you should provide to economic operators.

Now, this is a good thing and a bad thing, because especially for economic operators. There are actually, it happens, quite a lot that even competitors distribute each other's products. So you would. And if you look, if you look at the kind of information that is asked in the reporting form for the competent authority that can be very strategic information in there that you do not want your competitors to have. So yeah, what you should definitely avoid as a company is to just send your economic operators the same form as you would send to the competent authorities. I mean, you can, but it might not be smart.

Then the question is, what are you going to send them? So you need to have. Basically, you need to have made a good decision on that. Why is it also very important? And this also goes to the very, very good point that Basil made just now about timing is that if you, this distribution agreements in the supply chain are all about continuity, right? So the distributor forecast and you supply. and if the distributor doesn't forecast or doesn't meet targets, or you as a manufacturer, are enabled to supply, or you don't meet the demand of the distributor. There may be default under the agreement. and depending on what you agree in the agreement, or depending on what national law allows. There may be even a ground for the distributor to claim a so-called anticipatory breach in their distribution agreement. If you have to inform them, hey? I might not be able to supply

right? So it might be that this gives legal ground for the distributors. Say, Hey, guys, you are in default under the distribution agreement. We want damages, replacement products from another company we terminate the distribution agreement, all that kind of stuff. Same with situations. Where, let's say, for example. you have a distributor that has a tender agreement with the customer or Us. Manufacturer have tender agreement with a health institution directly tender agreements are usually not very negotiated. so as soon as you tell the health institution I might not be able to supply, there can be all kinds of Draconic

legal consequences. So you really need to think about this and also map for your supply chain like, what will it mean if we send this cascade of information into the supply chain. I mean, the Commission probably thought, oh, it's easy. We will just make these people tell each other, but it also means that you get all kinds of legal effects propagating in the supply chain. Then there's also the matter of what will you tell the authorities? Exactly. Because, although the Q. And a. Says that the information provided in the form to the competent authorities should be confidential. If you look in Article 109 Mdr. And the corresponding provision in the in the Ivr. It says, this information is confidential.

subject to national provisions on freedom of information. So that means that if you have a local, competent authority that is actually pretty, let's say, liberal in what it thinks is free is falls in the scope of Freedom of Information act they may still may still just give like, I don't know, maybe not 100% of the form, but they may give you an 80% of the form. So what I expect is that we will get quite an interesting sport of trying to figure out what exactly the nature of the supply restrictions of competitors is by means of freedom of information request. And if you do this with the Dutch authorities, for example, we litigate a lot against them

for provision of vigilance, reporting form information to parties that are preparing products, product, liability, litigation. I am amazed by the level of detail that the authorities are willing to disclose. So you also need to think about that actually.

It's a very good point, because what we need to consider here, when we look into all of this information and sharing of information that the supply. When you are sharing information, it goes up to the physicians as well to the hospitals. So you are sharing information. You are telling about potential interruption of product availability. And those reports, if you overreport. you might create rumors on the market, whereas there is nothing you are just trying to meet the requirement. You might create rumors that people, physicians, distributors, importer. They start telling. This manufacturer is under trouble. They have always interruption or potential interruption, or this manufacturer might be closing out because they don't want to deliver any more product. So the message providing should be very clear, and you should be very careful on

setting your system in such a way that just for the relevant devices, because I hear a lot of people saying I have a class one. I have a class 2, A, I have a class 2 BI have a class 3, implantable. Do I need to report? You need to look to your device it's characteristic, and it can be in any class. Important is is an interruption of such a device going to impact the health care system by having a situation which is critical. So you need to look to the serious impact on the healthcare system. And it's not about actually a syringe supply. But if you are the only syringe supplier on the market, then we cannot inject any any drug anymore. Then it is. But if you are actually number 150 supplier.

You might not be like that critical. And this is where you need to look into the situation. You build your system. You have an evaluation. You have like you, said Loris. Before. How can I set my system? Can I set it in the right way? You need to understand what is relevant in your kind of business because you could be a supportive device for a surgical procedure, and if you are not available, the surgical procedure will not happen. So it is important to understand what is the device doing and where it is involved, and how critical is such a discontinuation or interruption of market availability on the healthcare system.

and we are not talking about devices which are nice to have. So if you have a device which will give me a better life. But I will not have patient dying. If they don't get it, then you will be able to justify. You are not impacted. This is why going back to your slide, Lawrence. Very important. Evaluate your own organization, evaluate your portfolio. and then decide, how can I set the system in a way that I'm meeting the requirement. But I'm not over reporting information and not under reporting information. You need to find the balance. That's why processes, training and education of the team and updates of agreement are key to make sure that you are actually meeting the requirements.

Yeah, yeah, updates of agreements from a legal perspective. I can't overemphasize this because that will avoid that, that you will get these legal triggers that I just referred to wonderful. And even I think also especially on a tender level. I mean, we've we've discussed a lot about what the responsibility of the manufacturers is. I think, also the fact that Article 10 A exists also should prompt health institutions to think about. Hey, how replace, how substitutable is what I'm doing. Actually, yeah. So let's say, for example, the the you have a system for particular forms of surgery that Basil just referred to. Is it smart of a hospital

to basically completely go all in on a single system for a single type of surgery purely based on costs when it could be that when this system is suddenly not available, it takes them 6 months to retrain the surgeons on another system. I mean this can also, and I think it also should not be only the manufacturer's problem that health institutions make not so smart decisions on this point. I mean, of course this is not accounted for in Article 10 a per se. But I think it is. It does raise the point that competent authorities, when they look at this also should actually conclude that the resilience of the system might also need to improve on a health institution level.

Right this should raise some very interesting questions for all the stakeholders involved. Absolutely. I'm sure there are a lot of questions from the audience. So let's.

I already took the liberty to answer a number, I hope. That's okay. I couldn't help myself.

No, of course, absolutely, I'm sure. I mean, that is the value of having this.

Are not happy with the answer, then they can just repeat the question, perhaps, or.

Absolutely so. Let's see, what what do we have from the audience? Sean, do you have any questions coming in.

So I don't think this one has been answered. Is it to be expected that the notified bodies will assess the implementation of article 10. A. In the next audits.

A very, I think. because it is. It is part of the obligation of the notified body to check compliance to the Mdr. And the Mdr. Include a specific focus on manufacturer obligation which are stipulated in Article 10. So the notified body's task is not to review what you submitted to the authority. They want to see that you have a system in place. You have an obligation to have a quality management system which is meeting the Mdr. And they're going to be checking if you actually address the regulatory obligation. And if we look back to the Mdr. The Mdr. Expect manufacturer to identify regulatory changes, and to actually make sure that they are addressed. And this obligation is not new, and it has a deadline. So if you you'll get an audit

after 10th of January. Be sure, when they're going to be auditing your system, they're gonna check. Did you address it? And how you are doing that? Because this is part of the obligation which you need to fulfill.

Yeah, yeah, very simple. It's a requirement by 10 January, and if it's a requirement they can raise a nonconformity against the requirement. If it's not implemented. So it's easy as that. The question is, of course, also to what level of detail they're going to look into it, because I've seen. For example, I think a nice example is the is the requirement in the Mdr. In Article 10, for example, to have sufficient coverage in case of product liability, which is a really interesting requirement. because I've never seen a notified body that actually knew what it was doing when it was asking questions about it, because you would have auditors with 0 legal qualification that were asking questions that were very legal.

So yeah. Also here, I think notified bodies will start very slowly, 1st by checking. Is there a procedure, then learning about what they see in different types of procedures? And then, when they have the feeling that there's that they have kind of a benchmark. On. What? What is state of art in these procedures? Then they will start to look for deviations to that benchmark. But that will not be the 1st audit cycle. I think.

I think it will be. It will be multiple steps like you said the most important initial step that you have to do. Identification implementation of processes, training of resources. So you need to have dedicated people responsible for this task. You can't just say I have a process, but it's not integrated in your quality management system. And they're gonna look to. Are you making use of your process? Did you have any cases? Or do you have a justification that is not applicable for you. So it might be for your kind of devices that you are actually a device which is supportive. But it is not essential for the healthcare system. So you might need to to build a justification. But make sure that you have documented evidence. Don't tell them. Yes, we are doing this without documented evidence which are actually integrated in your quality management system.

Very good. This next question has been asked by a number of people in a number of different ways, and you've spoken around this to a certain extent. But I'm just going to go ahead and read one of them. If the manufacturer knows that their device which meets the definition in Article 10. A is not the only alternative on the market, and, in fact, it is one of several alternatives that they still need to notify the authority in case of shortages, supply interruptions. The question that comes up over and over again is around alternatives, and whether or not you're obliged to know what the alternatives are and to what extent you are responsible for the fact that there are alternatives or there are not alternatives. And so I mean, this is kind of a confusing question.

Yeah, I think it's not confusing. I mean, I hope, that every manufacturers knows about the alternatives if they are good business leaders, because if you are actually placing device on the market, you need to know with whom I'm competing, and you need to understand that market landscape. So you would not actually just keep it running without looking to the competition. Now you have 2 cases. You can be actually having the smallest market share, and you might be able to justify simply that you are not having a big impact because they will digest so quickly. But you might have a case that there is a lot of additional competition, but you have 80% of the market share. So if you will disappear, they will not be able to ramp up their production. So it's not just about actually having competition. But is the competition able as well to take over the market if you disappear in a period of time all of these things would need to be considered, but I think Eric will can add some additional legal expectation on that.

Yeah, I think what Basil mentions about you manufacturers needing to know the competitive landscape. It's it's interesting that there's even a post-market surveillance obligation to do so right, because your post market surveillance plan actually needs to also address intelligence on on other manufacturers devices that can be irrelevant for your own device. So that would basically necessarily be competitors. So if you don't know, then you are also doing something wrong in your post market surveillance. That would also be an interesting vector for notified bodies to approach this. By the way, if I were a notified body, this is probably where my would be my next step after just looking. If you have a procedure, I would say, how does this connect to somebody's post market surveillance system?

Yeah. And then. of course, you get into the really difficult, let's say almost pinball machine of the Q. And a. The Commission's Q, and a. With all these factors that they give in section 9.2, because this, of course, it's all risk management, right and risk management is depending on who you ask. Yes, an exact science or no, an exact science. but I mean, there can be all kinds of factors that are relevant to a substitutability like, for example, I think the the 80% market share factor that Basil gave is a really interesting one. The fact that systems may be very specific and require a lot of training that I gave maybe irrelevant

but also The question like, for example, is there required infrastructure, for example, and and I would even say, and this is actually also one that is not addressed in a lot of detail in the Q. And a. To what medical state of art should there be substitutability? Right? Let's say, for example, you have a very advanced surgical robotic system for microsurgery. I mean this, this usually is surgery that you could also do by hand, except that the results might probably not be as fantastic as they would be with the robotic system. But there is, there is an alternative. Right?

So also, there you have the question like, how yeah. Should should substitutability be to the exact same clinical state of art or not? These are all questions, but in the end, in the end, what you can. What I've basically seen with the authorities is what what they want is that patients do not suffer interruptions from therapy. For example, this is this is, this is like what they really want to avoid. Harm caused as a result of hospitals needing to send people home hospitals, not being able to treat people or hospitals suddenly, not being able to provide the the level of care.

So this in the end, should be sort of the leading principle. When you make this risk assessment, I think, and this is also what your justification should gear towards.

Hmm. so the last question, because we're just about out of time. And I would like to remind everybody that I've put the link to the survey in the chat, so please complete the survey. But in the gray area. No one says the manufacturer needs to bunker purchase supplies in stock for 6 months of production. Could the new provision be interpreted as dictating that now they may need to.

No, no, what it it does mention bridging stock, as a let's say, also factor to take into account for the risk management. This assessment, the risk assessment that you need to make. So, for example, if the manufacturer can say, Oh, but hey! I actually have. I am going to suffer an interruption of supply. But then, again, I also have a year of bridging stock in my stocks. This can go into the risk assessment. What I find interesting personally is that the Commission has opted for the Q&A to to not address whether or not the manufacturer knows how much

stock there is in the supply chain, because some manufacturers will know this and others do not. This is not an explicit factor that is mentioned in the Q. And a. But I think also, I mean, if you, as a manufacturer, have an integrated supply chain, and you just know that there is sufficient stock in the supply chain. That may also be a justification to say, Look, there won't be there won't in the end be any harm, because there won't be an interruption of supply at health institution level, because the supply chain is sufficiently loaded.

Understood. Well, we're just about out of time. There were many, many questions that we didn't get to. We will try to follow up with those in writing. I'd like to thank the speakers again today, and I would like to encourage you to reach out to them as well, and I would allow the speakers to say goodbye. If they'd like to. And we will, we will close. We'll see you for the next webinar on orphan devices. On January 21.st

Thank you so much, Sean. Thank you, everyone for attending as well this event, and looking forward to the next event.

Thanks for all the good questions and the active participation in the chat. This was really helpful also for us to see what questions people actually have. And yeah, I would say, read the Q. And a. Put it under your pillow over the Christmas holiday. See if you can absorb it by osmosis. Some procedure is better than no procedure. And yeah, don't wait until you get called out by somebody that says, Why, why is there nothing? So something is always better than nothing. At the only days.

Happy Holidays, everyone.

Thank you. Everyone.

Thanks everyone. Everyone, bye, bye.